Vasomotor symptoms are reported by 60-80% of menopausal women (Gold et al., Am J Public Health, 2006, 96:1226-35) and approximately one-third of this population reports symptoms severe enough to seek treatment (Stearns et al., Lancet, 2002, 360:1851-1861). Vasomotor symptoms include hot flashes, hot flushes, and night sweats. Hot flashes are manifested as in increase in skin temperature and are often accompanied by a sudden onset of sweating on the face, neck and/or chest. Hot flashes and other vasomotor symptoms are commonly, but not exclusively, associated with females in a perimenopausal, menopausal or postmenopausal state.
The currently preferred treatment for menopausal symptoms, including vasomotor symptoms, is hormone replacement therapy using either estrogen or an estrogen/progesterone combination. While estrogens are an effective treatment for vasomotor symptoms (Nelson et al., AHRQ Publication No. 05-E016-2, 2005), concerns have been raised about the increased risk of uterine cancer, breast cancer and cardiovascular events associated with use of estrogen-based postmenopausal hormone therapy. Estrogen therapy is also contraindicated in patients previously diagnosed with breast cancer as estrogen and progesterone may be associated with an increased risk of cancer recurrence and are known to specifically promote growth of breast cancer cell with estrogen receptors. The use of selective serotonin reuptake inhibitors have shown modest efficacy in the treatment of hot flashes but have side effects that limit their use (Grady, N Engl J Med, 2006, 355:2338-47).
There are also numerous non-hormonal remedies commonly used by women suffering hot flashes including, for example, isoflavone, black cohosh, vitamin E, and the antidepressants fluoxetine, paroxetine, and venlafaxine. However, efficacy of these remedies is less than that of the hormone replacement therapies. A clinical trial with the plant-derived ERβ-selective extract, MF101 found a significant reduction of hot flashes in postmenopausal women (see U.S. Pat. No. 7,482,029).
Thus, there is a need for therapeutic compositions and methods for the treatment of the symptoms of perimenopause, menopause and/or postmenopause including hot flashes. There is a particular need for therapeutic compositions for the treatment or amelioration of menopausal symptoms that does not promote or increase the risk of cancers including breast cancer and uterine cancer.